The United States Department of Justice (DOJ) recently updated its Justice Manual and formalized the policies it had previously announced regarding reliance on subregulatory guidance in enforcement actions.

Previous Policy Statements

On November 16, 2017, then-Attorney General Jeff Sessions promulgated a memorandum titled “Prohibition on Improper Guidance Documents,” which announced guidelines governing DOJ’s issuance of guidance that has not been subject to notice-and-comment rulemaking. Specifically, the Attorney General wrote: “Effective immediately, Department components may not issue guidance documents that purport to create rights or obligations binding on persons or entities outside the Executive Branch.” Further, the policy prohibited DOJ guidance documents from being “used for the purpose of coercing persons or entities outside the federal government into taking any action or refraining from taking any action beyond what is required by the terms of the applicable statute or regulation.”

In January 2018, then-Associate Attorney General Rachel Brand issued the Brand memo, which announced a significant gloss on the Sessions memo for affirmative civil enforcement cases. While the Sessions memo focused on DOJ’s promulgation and use of its own guidance documents, the Brand memo expanded this policy to all agency guidance documents, preventing DOJ from allowing subregulatory guidance to impose new legal obligations by prohibiting DOJ from using “its enforcement authority to effectively convert agency guidance documents into binding rules.”

Justice Manual Updates

In December 2018, DOJ added section 1-20.000 to the Justice Manual, titled “Limitation on Use of Guidance Documents in Litigation,” which reiterated the Brand memo’s directive and applied it to both civil and criminal enforcement actions by all DOJ employees. Section 1.20.100 states several “general principles,” including these:

  • “Criminal and civil enforcement actions brought by the Department must be based on violations of applicable legal requirements, not mere noncompliance with guidance documents issued by federal agencies, because guidance documents cannot by themselves create binding requirements that do not already exist by statute or regulation.”
  • “The Department must establish a violation by reference to statutes and regulations. The Department may not bring actions based solely on allegations of noncompliance with guidance documents.”

One recurring question since the issuance of the Brand memo has been to what extent reliance on guidance documents is still permitted. The Brand memo suggested one example: When guidance documents paraphrase legal mandates, DOJ may use a party’s reading of that document to show the party’s awareness of the law. Additionally, in a February 2018 speech, Deputy Associate Attorney General Stephen Cox restated the Brand example and offered another similar, potentially permissible use: that a party may receive confirmation from counsel that an agency’s interpretation of law is “reflective of binding judicial precedent,” which could be relevant to the party’s knowledge.

The Justice Manual goes further and lists five nonexhaustive “illustrations” of appropriate use of guidance documents:

  1. To establish scienter, notice, knowledge and mens rea. This example resonates with those articulated by Brand and Cox, though the Justice Manual includes an additional scenario of appropriate use that raises more questions about its scope: guidance documents can be relevant to mens rea where “a party has submitted a false claim that is contrary to fact, but was crafted in a way that otherwise appears to be consistent with a guidance document, or where a party’s deliberate indifference to a guidance document is probative of deliberate indifference to the requirements imposed by statute, regulation, or other obligation.” The Justice Manual does clarify Cox’s comments by noting that awareness of an agency’s subregulatory legal interpretation does not constitute an admission that the interpretation is correct.
  2. As “probative evidence that a party has satisfied, or failed to satisfy, professional or industry standards or practices relating to applicable statutory or regulatory requirements.” In this regard, standards set in healthcare agencies’ guidance documents could help to establish whether a treatment was medically reasonable and necessary. Additionally, guidance documents could be used to establish “a duty, custom, or practice with respect to a government agency” in the same manner that an internal corporate manual may prove such a duty with respect to a private corporation.
  3. As reflective of a scientific or technical process that is generally accepted in that field.
  4. When the party’s compliance or failure to comply with guidance is relevant, such as when a party certifies compliance with a guidance document.
  5. To provide legal or factual context, such as in the background section of a brief.

The Justice Manual updates leave questions unanswered, the most significant of which is likely how broadly DOJ will use guidance documents when establishing a culpable state of mind, that is, whether that exception will swallow the rule. Nonetheless, DOJ’s further codifying of the recently announced policies signals that DOJ is serious about changing its reliance on nonbinding agency guidance.